Maximum Strength Mucus Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 1200 mg

PURPOSE

OTC - PURPOSE SECTION

Expectorant

USE(S)

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNING

WARNINGS SECTION

.

DO NOT USE

OTC - DO NOT USE SECTION

for children under 12 years of age

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

IF PREGNANT OR BREAST-FEEDING,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regard for the timing of meals
• adults and children 12 years of age and over: 1 tablet every 12 hours.  
• Do not exceed 2 tablets in 24 hours.
• children under 12 years of age: do not use

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
• store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENT SECTION

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

OTC - QUESTIONS SECTION

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number. 

HOW SUPPLIED

How Supplied Section

NDC: 63629-8348-1: 28 Tablets in a BOTTLE

NDC: 63629-8348-2: 180 Tablets in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin ER 1200mg Tablet

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

• Maximum Strength Mucus Relief
• Guaifenesin
• CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
• HYPROMELLOSE 2208 (100000 MPA.S)
• MICROCRYSTALLINE CELLULOSE
• POVIDONE, UNSPECIFIED

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.